Your Weekly Biotech News Fix | Ep. 722
The Week of 6.30.25
Hello Avatar! Another week of biotech news is in the history books. We are proud to bring you the latest edition of Sweat Equity, our weekly biotech news fix. The content is designed to be consumed as a quick scroll to bring readers up to speed on key events from the week. For those of you interested to read a bit more, we provide links to the source articles.
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BIOTECH NEWS UPDATES FOR THE WEEK 6/30
FDA Mulls ‘Regulatory Action’ on Argenx’s Vyvgart Hytrulo Over Severe Safety Concerns
The Food and Drug Administration (FDA) is reportedly considering whether to take regulatory action after detecting a severe safety signal in Argenx's drug Vyvgart Hytrulo. The concern is linked to the risk of severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) associated with the drug, a neonatal Fc receptor blocker administered via subcutaneous injection and approved to treat this disease and generalized myasthenia gravis (gMG). The safety update has caused share volatility for Argenx, with a decrease of up to 8% intraday on Monday.
Despite a "perceived risk of potential labeling language changes" according to analysts from William Blair, they believe the key aspect is clinician education on drug switching procedures. The Vyvgart franchise, including Vyvgart Hytrulo, is Argenx's only commercial presence, but it's one that analysts have high hopes for. In 2024 alone, Vyvgart products generated $2.2 billion. Nevertheless, the drug's revenue could be at risk due to its potential loss of exclusivity as early as 2033, leading Argenx to advance a pipeline of investigational therapies.
Regeneron Scores Multiple Myeloma Nod for Bispecific, Unlocking $600M Opportunity
Regeneron has gained accelerated approval from the Food and Drug Administration (FDA) for its bispecific antibody linvoseltamab, marketed as Lynozyfic, for treatment of relapsed or refractory multiple myeloma cases. BMO Capital Markets anticipates a potential $600 million revenue from Lynozyfic, terming it a minor contributor to Regeneron’s overall product collection. Despite running behind similar drugs such as Johnson & Johnson’s Tecvayli, which gained approval in 2022 and has a three-year advantage, Regeneron remains optimistic about differentiating on lines of effectiveness.
Lynozyfic drives T cells to eradicate multiple myeloma cells by binding the BCMA and CD3 proteins. The FDA had initially rejected this drug in August 2024 due to manufacturing issues at a third-party site. Notably, Lynozyfic is unique for its action mode, being the only bispecific that can be dosed bi-weekly and even extended to every four weeks if the patient shows considerable improvement. Sundar Jagannath, Network Director of the Center of Excellence for Multiple Myeloma at Mount Sinai, applauded Lynozyfic for its convenient response-adapted dosage and potential to reduce the patient’s treatment burden.
Late-Stage Stumble for Cosentyx Sets Novartis Back in Autoimmune Condition
Novartis' anti-inflammatory antibody, Cosentyx, has stumbled in a late-stage trial, failing to significantly improve remission in a Phase III trial of giant cell arteritis (GCA). In this trial, Cosentyx did not show any significant statistical difference from the placebo in either the primary outcome of sustained remission at 52 weeks or secondary outcomes such as cumulative steroid dose and steroid-related toxicities. The findings come from the GCAptAIN study that enrolled over 350 GCA patients and compared patients who received either a 300mg or 150mg dose of Cosentyx alongside a 26-week steroid taper with those given a placebo and a 52-week steroid taper.
This failure sets Novartis back in its attempts to challenge AbbVie's JAK inhibitor Rinvoq, which received FDA approval for GCA in April. Late-stage data supporting Rinvoq's approval showed 46.4% of patients achieving sustained remission from weeks 12 through 52, compared to 29% of placebo comparators, demonstrating a statistically significant treatment effect. As of yet, Novartis has not disclosed its future regulatory plans for Cosentyx in GCA, only indicating that it is still conducting a full analysis of the GCAptAIN trial and will release full findings at a later date.
Argenx Makes $1.5B+ Play for UNP’s Macrocyclic Peptides Aimed at ‘Undruggable’ Targets
Argenx has entered a research pact worth up to $1.5 billion with Unnatural Products, Inc. (UNP) to develop oral macrocyclic peptides for several traditionally undruggable disease targets. The deal involves a multi-million-dollar upfront payment to UNP, whose exact amount has not been disclosed. In addition to the upfront payment, UNP is also eligible for up to $1.5 billion in future research, development, regulatory, commercial milestones and option commitments. UNP also stands to receive tiered royalties on net sales of products resulting from the collaboration. This comes as the largest licensing deal in the macrocyclic peptide space to date, and Argenx has pledged to participate in UNP's upcoming series B fundraising round.
UNP's proprietary drug discovery platform, an AI-driven engine capable of generating synthetic peptides that mimic macrocycles, is at the heart of this partnership. The molecules generated can bind to complex targets like biologics do and can easily pass through the cell membrane like small molecule drugs. Under the terms of the agreement, UNP will apply its macrocyclic peptide technology to discover orally available drug candidates for multiple targets as identified by Argenx. These compounds will then undergo initial assessments and investigational new drug-enabling studies, after which Argenx will have the option to advance them to clinical studies.
Sage’s Search for Lifeline Ran Into Defiant Biogen CEO
Sage Therapeutics, after facing Food and Drug Administration (FDA) rejection of its depression drug Zurzuave in one type of depression and the triple failure of its neuro asset dalzanemdor, was on a quest for a financial lifeline by the end of December 2024. The company sought assistance from 43 different partners throughout 2024 and into 2025, culminating in a potential $795 million acquisition by Supernus Pharma. The central focus of the deal was Zurzuave, which had received FDA approval for post-partum depression in August 2023, but was denied the more lucrative major depressive disorder indication.
In the aftermath of FDA rejection and the failure of dalzanemdor, Sage found its survival dependent on a potential royalty financing deal which could have provided up to $200 million in capital. However, discussions regarding this deal led to another proposition: Biogen CEO, Chris Viehbacher, suggested the acquisition of Sage. This proposal was promptly declined by Sage's executives, believing that the royalty transaction was a more viable solution. Despite their decision, Viehbacher returned with a more compelling offer, which was also declined. Soon after, he hinted at an unsolicited offer to purchase Sage, a revelation that CEO Barry Greene believed violated standing company agreements.
Biotech Leaders, Investors Ask FDA to Maintain Access to Mifepristone
Over 50 executives from the biotech industry and life sciences investors have signed an open letter to the FDA urging the organization not to limit patient access to the abortion pill, mifepristone. Their letter serves as a response to an April report by the anti-abortion advocacy group, Ethics and Public Policy Center (EPPC), which alleges that more than 10% of women taking mifepristone experienced serious adverse events including hemorrhages and sepsis. Following the EPPC report, the FDA had been instructed by Health Secretary Robert F. Kennedy Jr. in May to review its regulations regarding the abortion drug, a move which has been criticized by the open letter signatories as fundamentally flawed with several methodological faults. The signatories include industry leaders such as Arcutis CEO Frank Watanabe and Nkarta CEO Paul Hastings, as well as RA Capital Management partner Peter Kolchinsky, and venture capital investor Nina Kjellson.
The biotech executives and investors emphasize that greater restrictions on mifepristone would be a deviation from the FDA's usual rigourous scientific evaluation process. They criticize the report's lack of transparency, arguing it has not been peer-reviewed and its data has not been made available for other researchers in the field to validate. The signees argue that there is overwhelming evidence supporting both the efficacy and safety of mifepristone, and suggest that any decision to limit access based on unverified and flawed data would open the door for political or interest groups to manipulate FDA's decisions. This advocacy surrounding mifepristone continues to highlight it as a politically contentious issue in the U.S.
Gilead Eyes HIV Market Domination With Twice-Yearly Yeztugo as GSK Trails
Gilead Sciences is aiming to tighten its grip on the HIV market with their newly approved semi-annual HIV prevention drug, Yeztugo, predicted to reach peak sales of $4.5 billion. This move is expected to pose a significant threat to GlaxoSmithKline (GSK) and generics manufacturers and potentially expand Gilead's market share. In 2024, Gilead's HIV products, led by Biktarvy and Descovy, generated $19.6 billion, with Biktarvy alone contributing $13.4 billion. Descovy, another HIV treatment and prevention drug, competes with GSK's semi-monthly injectable, Apretude, in the pre-exposure prophylaxis (PrEP) market. According to Gilead’s chief commercial officer, Johanna Mercier, Descovy maintained over a 40% market share and grew more than 2% year over year.
The analyst consensus predicts Yeztugo's peak sales at around $4.5 billion. Gilead's CEO, Daniel O'Day, outlined a three-pronged patient targeting strategy at a recent Goldman Sachs event, expressing a plan to convert the 400,000 to 450,000 current PrEP users in the U.S. to Yeztugo. O’Day highlighted that the new drug could enhance treatment compliance, currently sitting at around 50% for daily pills. One HIV doctor indicated that Yeztugo may be a popular choice among current PrEP users, believing that the "vast majority" of Apretude users and the "majority" of daily oral PrEP users may switch to Yeztugo.
Bluebird Go-Private Deal Signals the ‘PE-ization of Pharma’
The Carlyle Group, a private equity firm managing $453 billion, has recently purchased gene therapy biotech firm, bluebird bio, in collaboration with another private equity firm, SK Capital Partners, which manages $10 billion. The biotech company was bought for under $50 million. The deal raised eyebrows, particularly as another buyer, Ayrmid (parent company of fellow cell therapy biotech firm Gamida Cell), proposed a potentially more agreeable offer. However, bluebird opted for the private equity buyout, seemingly pushing away the alternate proposal and prompting financing on a day when markets had shut.
The acquisition of bluebird bio represents a noticeable development termed as "PE-ization of pharma", according to Kazi Helal, a senior biotech analyst at PitchBook. Traditionally, private equity has been entrenched in pharma-related specialties such as research organizations, manufacturers, and service providers. These dealings generally follow the textbook private equity strategy, where firms make purchases and implement changes to maximize profit, often merging the acquired company with other entities and consequently selling it within a shorter timeframe. However, firms specializing in drug manufacturing have been relatively challenging for private equities. Nevertheless, this eventful transaction indicates a positive shift in the trend.
Beckley’s Psychedelic Nasal Spray Clears Phase II Depression Study
Beckley Psytech's new psychedelic nasal spray, BPL-003, has demonstrated strong efficacy in a Phase II study treating patients with treatment-resistant depression. Jefferies analysts highlighted the drug's robust data and suggest that BPL-003 could reach peak market sales of $1 billion. The successful results also pave the ground for late-stage development of the drug and the close of the proposed merger between Beckley and Atai Life Sciences, the latter being contingent upon the success of BPL-003’s mid-stage development.
In the study, patients treated with 12-mg BPL-003 saw an 11.1-point reduction from their baseline scores on the Montgomery-Ã…sberg Depression Rating Scale (MADRS), compared with a 5.8-point drop for controls taking a 0.3 mg dose. This effect was statistically significant and was achieved after just one dose of the drug. Moreover, the beneficial effects of the treatment endured for eight weeks. The readout, according to Jefferies analysts, supports the idea that psychedelics can safely produce deep efficacy for challenging central nervous system disorders. Beckley, a private U.K. firm, is currently merging with Berlin-based atai.
CONCLUSION
There you have it, another week of SWEAT EQUITY - Your Weekly Biotech News Fix. We hope you enjoyed it, please drop a comment with any feedback you may have.
We are now publishing 7x per week according to the following cadence:
Mondays: Stocks
Tuesdays: Biotech
Wednesdays: Podcast
Thursdays: Markets
Fridays: News
Saturdays: Podcast
Sundays: Strategy
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