Biotech Breakfast-Major Health Groups Mixed; Nature Medicine Investigates Wegovy, Ozempic Suicidal Ideation Risk, AxoGen and Inovio Surge

Dow +0.07%, S&P 500 +0.18%, Nasdaq +0.09%, Russell 2000 (0.34%)

Healthcare equities were largely unchanged by the closing bell following a choppy session on Friday. Healthcare settled down (0.02%) versus the S&P 500 which gained +0.18%. Major health groups ended the day mixed, possibly due to final positioning into the JPMorgan Healthcare Conference, as small cap companies delivered pipeline updates before their larger peers dominate the headlines next week.

Notable gainers during the day were AxoGen ($AXGN) which rose +26.7% on reporting preliminary Q4 revenue and announcing its strategy following CEO Karen Zaderej’s retirement, which is expected by January 2025. Immunovant ($IMVT) gained +10.0% and was the best performer on the XBI, and TG Therapeutics ($TGTX) was up +9.0%.

PRISM MarketView’s Emerging Biotech Index tracks the progress of micro and small cap companies contributing to  healthcare innovation and economic growth. Top performers on Friday were Inovio Pharmaceuticals ($INO) which was up 25.76% after announcing on Thursday that it had entered a clinical collaboration and supply agreement with Coherus BioSciences, Inc. ($CHRS). Addex Therapeutics ($ADXN) which gained 9.55% after announcing it will present at the 2024 Biotech Showcase, and Equillium, Inc. ($EQ) which rose by 7.21%. The day saw declines from AIM ImmunoTech ($AIM) which lost 8.14%, and Biodexa Pharmaceuticals ($BDRX) which dropped by 7.29%.

Dying to be Thin?

A National Institutes of Health (NIH)-funded analysis has found that Novo Nordisk’s ($NVO) Wegovy and Ozempic (semaglutide) are associated with a lower risk of suicidal ideation compared with other treatments for obesity or Type 2 diabetes. The study showed that semaglutide was associated with a 49% to 73% lower risk of first-time or recurring suicidal ideations, compared to other medications that work via different mechanisms. The study’s authors concluded that results do not support concerns of increased suicidal risk associated with semaglutide and highlighted the need for a more detailed evaluation of reported cases to date.

In July 2023, Europe’s Pharmacovigilance Risk Assessment Committee (PRAC) opened an investigation into a safety signal of suicidal ideation and announced in November that the investigation was ongoing with an update expected in April 2024. Also in July, the European Medicines Agency (EMA) highlighted potential risk of thyroid cancer associated with GLP-1 drugs, and asked manufacturers to submit supplementary information related to the matter.

The FDA has also announced a probe into reports of side effects including hair loss and suicidal thoughts resulting from drugs including Ozempic, Mounjaro and Wegovy this week. If the FDA determines that the drug is associated with the risk, it may require changes to the labeling of the drug, it may request the development of a Risk Evaluation and Mitigation Strategy (REMS) among other potential actions.

 The Trader’s Lens

Catalyst Pharmaceuticals Partners Inc.

$CPRX gapped down Friday after Thursday’s announcement of a $10 million public offering at $15 a share.

Inovio Pharmaceuticals, Inc.

$INO was Thursday’s leader in the Prism MarketView Biotech index, it’s also approaching and trying to make new 6 month highs.

The week’s headlines

Omega Therapeutics Surges 107% on Novo Nordisk Obesity R&D Partnership

Shares in Omega Therapeutics, Inc. (Nasdaq: OMGA) have surged today following news that the company has entered a research partnership with Novo Nordisk ($NVO) to develop a novel therapeutic for obesity management.

Better Therapeutics Targets FDA Breakthrough Device Designation for Liver Disease Treatment

Prescription digital therapeutics (PDTs) pioneer, Better Therapeutics (Nasdaq: BTTX), has submitted a request to the FDA for Breakthrough Device Designation for its novel PDT designed to treat metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH).

ABVC BioPharma Shares Soar After $460M Payday

ABVC BioPharma, Inc. (Nasdaq: ABVC) and its subsidiary BioLite, Inc have received an aggregate of 46 million shares from AiBtl BioPharma Inc. as its first milestone payment under a global licensing agreement. The agreement is valued at $460 million ($10 per share). ABVC’s shares soared during intraday trading to close up 60.83%.

Voyager Therapeutics Receives $100M Upfront in Novartis Collaboration

Voyager Therapeutics (Nasdaq: VYGR) has entered a strategic collaboration and license agreement with Novartis Pharma AG, a subsidiary of Novartis AG (NYSE: NVS) to advance potential gene therapies for Huntington’s disease (HD) and spinal muscular atrophy (SMA). Voyager will receive an upfront consideration of $100 million and is eligible to receive milestone payments and tiered royalties as part of the deal.

CollPlant Biotechnologies Evaluates 3D-Bioprinted Regenerative Breast Implants in Preclinical Study

Regenerative and aesthetics medicine company, CollPlant Biotechnologies (Nasdaq: CLGN) has initiated a preclinical trial to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. There is currently no commercially-available product that allows regeneration of soft tissues, such as the breast.

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About the Author

Biotech Breakfast-Major Health Groups Mixed; Nature Medicine Investigates Wegovy, Ozempic Suicidal Ideation Risk, AxoGen and Inovio Surge

Catie Corcoran

Biotech Editor