Roche’s Alecensa Gets FDA Green Light; ImmunityBio Gains as PDUFA Date Approaches for Bladder Cancer Drug; Key Drug Trial Failures in 2024

New York, N.Y., April 22, 2024 – PRISM MarketView – Healthcare equities finished mostly higher after a very quiet trading session on Friday. The S&P 500 Healthcare Index closed up +0.32% versus the S&P 500 Index which lost (0.88%) and the XBI settled down (0.78%). A lack of momentum today left Roche stock up by just +0.95% following the FDA greenlit approval for a label expansion for Genentech’s Alecensa (alectinib) for the adjuvant treatment of patients with non-small cell lung cancer. The approval came one month ahead of the PDUFA goal date. 

Notable performers on Friday were Adaptimmune Therapeutics ($ADAP) which gained +8.7% during the day, and a further 3.4% aftermarket, following the company’s investor day. ImmunityBio ($IBRX) was up +7.3% and the best performer on the XBI, as the company’s PDUFA date approaches for N-803 plus BCG for the treatment of BCG-unresponsive NMIBC. Community Health Systems ($CYH) finished the day up +3.1% after the company announced on Thursday that it had entered a definitive agreement to sell Cleveland, TN hospital to Hamilton Health Care System for $160 million in cash.

PRISM Index Gainers and Decliners

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 BioLineRx ($BLRX), which gained 2.56%, Adverum Biotechnologies ($ADVM), which rose 1.70%, and Lisata Therapeutics ($LSTA) which was up 1.12% to $2.70. Index decliners were Addex Therapeutics ($ADXN) which was down by 7.56%, Vaxart ($VXRT), which dropped by 10.29%, and Metagenomi ($MGX) which settled down 11.09% at the closing bell. The index has a current value of $197.60 and is up 97.6% since inception.

High Stakes: Seven Key Drug Trial Failures in 2024

The cost of developing a new drug – a process that can take between 10 and 15 years from concept to market – has risen to approximately $2.3 billion, and there are many opportunities for failure along the way. Around 90% of drug candidates in clinical trials fail, despite significant investments in time and money. 

Behind every drug trial failure is an army of people: researchers, clinicians, professionals and patients who have invested countless hours, resources and funding. These failures are disappointing for companies, particularly smaller biotechs who may not survive, and they can be devastating for patients desperate for new treatments.

Read more in this week’s Biotech Bulletin.


Disappointment for Sage Therapeutics as Parkinson’s Disease Trial Misses Endpoint

In a crushing disappointment for Sage Therapeutics (Nasdaq: SAGE) and the Parkinson’s disease community, the company reported on Wednesday that its double-blind, placebo-controlled Phase 2 study of dalzanemdor (SAGE-718) in Parkinson’s Disease (PD) did not meet its primary endpoint. Sage’s shares rallied +4.30% in intraday trading on Thursday after a difficult day on Wednesday. Based on the data, the company says it does not plan any further development of dalzanemdor in PD.

Positive Results for Lipocine in Obesity Study

Biopharmaceutical company, Lipocine Inc. (Nasdaq: LPCN) has announced positive results from a Phase 2 clinical trial evaluating LPCN 2401 for improving body composition by gaining lean mass and reducing fat mass. Lipocine believes that LPCN 2401 has potential as an adjunct therapy to GLP-1/GIP agonists.

IceCure Medical Requests FDA Marketing Authorization for Breast Cancer Cryoablation Technology

IceCure Medical Ltd. (Nasdaq: ICCM) has submitted final data to the FDA requesting marketing authorization for ProSense® as a treatment for early stage T1 invasive breast cancer with adjuvant hormone therapy. ProSense® is already cleared for use in the US for treating benign tumors of the breast, and tumors in the kidney and liver.

Moleculin Granted EMA Orphan Drug Designation for Leukemia Drug

Pharmaceutical company, Moleculin Biotech (Nasdaq: MBRX) has been granted Orphan Drug Designation for Annamycin in the treatment of acute myeloid leukemia (AML) by the European Medicines Agency (EMA). The company’s share price rose 6.31% following the news on Thursday.

CorMedix Catheter Infection Treatment Commercially Available in US

CorMedix Inc. (Nasdaq: CRMD) has announced that its DefenCath® (taurolidine and heparin) catheter lock solution (CLS) is now commercially available for inpatient use in the US. DefenCath® has received FDA approval for use in reducing the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter.

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