Biotech Breakfast – Healthcare Equities Flat, Moderna Shines, J&J Bladder Cancer Treatment Gets FDA Nod; Novartis Terminates Peanut Allergy Trial
Dow +1.05%, S&P 500 +1.23%, Nasdaq +1.70%, Russell 2000 +1.08%
Healthcare equities finished the week flat, with Healthcare up +0.06% versus the S&P 500 which rose +1.23%. Biotech traded higher in the afternoon, however the XBI closed down (0.01%), lower for the seventh straight session. Large-caps were relative performers in biotech, including Moderna ($MRNA) which gained +0.6%, the company’s first positive close in eight sessions.
In FDA news, the regulator approved Johnson & Johnson’s ($JNJ) supplemental New Drug Application (sNDA) for Balversa (erdafitinib) in the treatment of bladder cancer, saying it will allow the conversion from Accelerated approval to Traditional (full approval). Modular Medical ($MODD) has submitted its MODD1 next-generation insulin pump to the FDA for 510(k) clearance. Finally, Eli Lilly ($LLY) expects to receive its PDUFA for donanemab in Alzheimer’s Disease in early 2024.
Notable gainers during the day were Edgewise Therapeutics ($EWTX) which soared +34.6% after suspending its ATM offering and pricing an underwritten stock offering, Alvotech ($ALVO) rose by +15.3% and Silk Road Medical ($SILK) gained +12.7% after being upgraded to Buy at Stifel.
PRISM MarketView’s Emerging Biotech Index tracks the progress of micro and small cap companies contributing to healthcare innovation and economic growth. Top performers on Friday were Gamida Cell ($GMDA) which surged 27.04% after announcing this week that it will present new data on its cell therapies at the 2024 Meetings of the American Society for Transplantation and Cellular Therapy. Minerva Neurosciences ($NERV) was up 7.41%, and Equillium ($EQ) gained 4.96%. The day saw declines for Sorrento Therapeutics ($SRNEQ) which plummeted (50.0%), Athersys, Inc. ($ATHX) which dropped by (22.25%), and Bolt Biotherapeutics ($BOLT) which lost 8.19% by the closing bell.
The Wait Continues for Peanut Allergy Sufferers
Peanut allergies, affecting over six million Americans, range from mild discomfort to potentially fatal anaphylaxis. Aimmune Therapeutics’ PALFORZIA, approved by the FDA in 2020, remains the only FDA-approved oral immunotherapy for reducing allergic reactions, including anaphylaxis. However, the journey towards more solutions continues.
Novartis recently halted its Phase 3 trial of Ligelizumab, while its collaboration with Genentech on Xolair, already successful in treating allergic asthma, is now being explored for peanut allergies. Meanwhile, innovative treatments are on the horizon, with Intrommune Therapeutics testing a unique peanut protein toothpaste and DBV Technologies advancing with its promising ViaSkin™ Peanut patch, both showing encouraging results in clinical trials. For those affected, these developments represent a blend of breakthroughs and ongoing quests in the fight against peanut allergies.
Read more in today’s Biotech Bulletin
The Trader’s Lens
$BFRG is up over 100% this week after announcing positive early results with its collaboration with Lieber Institute for Brain Development.
Pharmaceutical company $ESPR is retesting its lows for the year so far at about $2.10.
The week’s headlines
Intelligent Bio Solutions Inc. (Nasdaq: INBS), a renowned leader in the medical technology sector, announced todayits significant contribution to modernizing the drug testing process at Robinson Brothers, a major independent chemical manufacturer in the UK.
Incannex Receives IRB Approval for Novel Cannabinoid Sleep Apnea Treatment Trial
Australian pharmaceutical company, Incannex Healthcare Inc. (Nasdaq: IXHL), has received independent Institutional Review Board (IRB) approval for a Phase 2/3 clinical trial to assess the safety and efficacy of its proprietary novel cannabinoid combination drug candidate IHL-42X in patients with obstructive sleep apnea (OSA). There are currently no approved pharmacotherapy treatments available to treat OSA.
Bullfrog AI (Nasdaq: BRFG) shares are up more than 32% in morning trading on Wednesday after the company announced a collaboration with the Lieber Institute for Brain Development (LIBD) that could revolutionize our understanding and treatment of psychiatric disorders. The company’s shares soared more than 30% in morning trading on Wednesday.
Lisata Treats First Patient in Glioblastoma Clinical Trial
Lisata Therapeutics (Nasdaq: LSTA) has treated the first patient in a Phase 2a trial evaluating LSTA1 in patients with newly diagnosed glioblastoma multiforme (GBM). The study is being conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients.
Vaxart Announces $10.0 Million Registered Direct Offering; Shares Climb 30%
Vaxart, Inc. (Nasdaq: VXRT) announced today that it had entered into a common stock purchase agreement with RA Capital Management for the sale of 15,384,615 shares of its common stock in a registered direct offering at an offering price of $0.65 per share. The gross proceeds of the deal will be approximately $10.0 million.
