Biotech Breakfast – Healthcare Equities Close Higher, Major Healthcare Groups Fare Well; Altimmune Soars while Pfizer Falls on Obesity Clinical Updates
Healthcare equities closed higher on Friday afternoon, with most major healthcare groups faring well. Healthcare closed up +0.11% versus the S&P 500 which rose +0.54%. Pharma underperformed during the day’s trading. In biotech research news, BioNTech ($BNTX) was downgraded to underweight from neutral at JPMorgan, while Needham & Company initiated coverage of Immuneering Corporation ($IMRX) with a buy rating and a target price of $20. Immuneering finished the day up 24.70%.
Other notable gainers during Friday trading were Apellis Pharmaceuticals ($APLS) which was up +14.0% after releasing study results showing data from three years of continuous treatment with SYFOVRE®, the first-ever FDA-approved treatment for geographic atrophy secondary to age-related macular degeneration. Rapt Therapeutics ($RAPT) rose +11.9% on results from its Phase 1a/1b study in atopic dermatitis. The day’s session saw declines from Pfizer ($PFE), down (5.7%) on trial results for GLP-1, danuglipron, in obesity, Caribou Biosciences ($CRBU) which dropped (4.4%), and Lifestance Health Group ($LFST) which was down (4.1%).
Obesity Dominates Headlines, Again
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) announced on Friday that following a review of evidence from clinical trials, post-marketing surveillance and published literature, it cannot conclude on a causal association between GLP-1 drugs and reported cases of suicidal thoughts and thoughts of self-harm. In a summary published today, the committee referred further questions to the marketing authorization holders of Ozempic, Wegovy and other approved GLP-1s, and will discuss at its meeting in April 2024.
In clinical news, Altimmune ($ALT) soared +15.0% following positive topline trial results demonstrating weight loss, robust reductions in triglycerides, LDL cholesterol and blood pressure, and strong safety profile of its GLP-1 obesity drug candidate, pemvidutide. Pfizer’s ($PFE) shares fell after the company announced topline data from its Phase 2b study of oral danuglipron for obesity. The study met its primary endpoint but disappointing reductions in weight and high participant discontinuation rates mean the company will not advance the drug into Phase 3 studies. CNBC also highlighted a real-world study that suggested Eli Lilly’s ($LLY) Mounjaro is more effective than Novo Nordisk’s ($NVO) Ozempic for weight loss in overweight and obese adults.
Psychedelics may also have a role in combating obesity. Last week, Clearmind Medicine ($CMND) and Scisparc ($SPRC) announced positive preclinical results from a study of their combination treatment, which includes Clearmind’s MEAI, a novel proprietary psychedelic treatment, and SciSparc’s CannAmide™, a cannabinoid mimetic lipid molecule. The study observed safety and the impact of the treatment on various metabolic and behavioral parameters including fat oxidation, locomotor activity, and feeding behavior in mice. Clearmind closed up +18.29% while Scisparc enjoyed a +2.0% boost at the closing bell on Friday.
PRISM MarketView’s Emerging Public Health Index tracks the progress of micro and small cap companies contributing to treatments that address significant threats to global health, including obesity.
The Trader’s Lens
Altimmune, Inc.
$ALT gapped up on Friday on news that in a Phase 2 trial, its drug Pemvidutide showed success in inducing weight loss. The results showed that more than 50% of enrollees achieved at least 15% weight loss, while more than 30% of people achieved at least 20% weight loss on certain doses.
ImmunoGen, Inc.
Cancer drug maker $IMGN was up over 80% on Thursday after it was announced that AbbVie agreed to buy ImmunoGen for $10.1 billion.
The week’s headlines
Biora Therapeutics Offers Hope to 1.8 Million Americans with Inflammatory Bowel Disease
Biora Therapeutics (Nasdaq: BIOR) has received FDA clearance for its Investigational New Drug (IND) application for BT-600, a drug/device combination for the treatment of moderate to severe ulcerative colitis. Biora believes this is the first active IND for an ingestible drug and device combination.
Positive Topline Results for Altimmune in Obesity Drug Trial; Shares up 41% in Morning Trading
Altimmune, Inc. (Nasdaq: ALT) has reported positive topline results from its 48-week MOMENTUM Phase 2 obesity trial of pemvidutide. Over 50% of subjects achieved at least 15% weight loss and over 30% of subjects achieved at least 20% weight loss on the 2.4 mg dose. The company’s share price rose more than 40% in morning trading on Friday.
Biodexa Asset Offers Potential to ‘Radically Improve’ Treatment for Diabetes Patients
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has entered into an agreement for the rights to develop and commercialize tolimidone under an exclusive, worldwide license from Melior Pharmaceuticals I, Inc. Biodexa plans to develop tolimidone for the treatment of Type-1 diabetes (T1D). The company’s share price rose more than 100%following the news.
Department of Defense to Study Seelos Therapeutics’ Ketamine Compound as PTSD Treatment
Seelos Therapeutics, Inc. (Nasdaq: SEEL) has announced that its drug candidate, SLS-002 (intranasal racemic ketamine), has been selected for inclusion in a clinical trial to evaluate treatments for post-traumatic stress disorder (PTSD) in active-duty service members and veterans.
Scisparc Using Psychedelics to Target Weight Loss
Scisparc Ltd. (Nasdaq: SPRC) has achieved positive results in a preclinical trial observing the safety and impact of a combination treatment on various metabolic and behavioral parameters including fat oxidation, locomotor activity, and feeding behavior.