The Daily Biotech Pulse: Biogen Faces Another Clinical Setback, CureVac's COVID-19 Vaccine Study Fails, Moment Of Reckoning For Orphazyme

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 16)

Alexion Pharmaceuticals, Inc. ALXN
Alzamend Neuro, Inc. Common Stock ALZN (IPOed Tuesday)
Citius Pharmaceuticals, Inc. CTXR
Dr. Reddy's Laboratories Limited RDY
Genmab A/S GMAB
Kindred Biosciences, Inc. KIN (announced a deal to be bought by Elanco Animal Health Incorporated (ELAN))
LeMaitre Vascular, Inc. LMAT
Misonix, Inc. MSON
Natus Medical Incorporated NTUS
Prometheus Biosciences, Inc. RXDX
Protagonist Therapeutics, Inc. PTGX
ShockWave Medical, Inc. SWAV
Supernus Pharmaceuticals, Inc. SUPN
Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 16)

AbCellera Biologics Inc. ABCL
Aptose Biosciences Inc. APTO
Happiness Biotech Group Limited HAPP
Inhibikase Therapeutics, Inc. IKT (reacted to the pricing of common stock offering)
ORIC Pharmaceuticals, Inc. ORIC
Pharming Group N.V. PHAR
Spruce Biosciences, Inc. SPRB
Vertex Pharmaceuticals Incorporated VRTX
Yumanity Therapeutics, Inc. YMTX

Stocks In Focus

Satsuma's Migraine Drug Candidate Aces Early Stage Study

Satsuma Pharmaceuticals, Inc. STSA announced positive pharmacokinetic, tolerability and safety results from a Phase 1 trial of STS101, showing that all three dose strengths administered with its improved second-generation nasal delivery device were well-tolerated and achieved the target pharmacokinetic profile. STS101 is being evaluated for migraines.

Based on results from this Phase 1 trial and other data — including preliminary results to date from the ongoing Phase 3 ASCEND long-term, open-label safety trial of STS101 5.2 mg — Satsuma is initiating its SUMMIT Phase 3 efficacy trial with the 5.2 mg dosage strength of STS101.

The company said top-line results from the SUMMIT trial are expected in the second half of 2022.

The stock rallied 17.78% to $5.83 in after-hours trading.

Cellect Files Registration Statement With SEC For Proposed Merger With Rare Disease Drug Company Quoin

Cellect Biotechnology Ltd. APOP said it has filed a registration statement with the SEC in connection with its proposed strategic merger with privately held Quoin Pharmaceuticals.

Quoin is a specialty pharmaceutical company focused on rare and orphan diseases. The transaction is currently expected to close in the third quarter.

Cellect shares jumped 56.88% to $5.13 in after-hours trading.

Pfizer Announces Positive Data For Tofacitinib In Patients Hospitalized With COVID-19 Pneumonia

Pfizer, Inc. PFE and the Academic Research Organization from the Hospital Israelita Albert Einstein announced that the New England Journal of Medicine has published positive findings from the STOP-COVID study evaluating the efficacy and safety of oral Janus kinase inhibitor tofacitinib in 289 hospitalized adult patients with COVID-19 pneumonia who were not on ventilation.

The trial conducted in Brazil demonstrated a lower cumulative incidence of death or respiratory failure through day 28 — the primary outcome of the study. Death from any cause through day 28 occurred in 2.8% of patients in the tofacitinib group and in 5.5% in the placebo group.

Pfizer stock added 0.18% to $39.37 in after-hours trading.

Biogen Pulls Plug On Alzheimer's Program Following Negative Results From Midstage Study

Biogen, Inc. BIIB said the Phase 2 TANGO study of gosuranemab did not meet its primary efficacy endpoint of change from baseline at week 78 on the Clinical Dementia Rating Scale-Sum of Boxes compared to placebo in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia.

Based on these results, the TANGO study has been terminated. Biogen also said it will discontinue clinical development of gosuranemab.

CureVac COVID-19 Vaccine Candidate Flunks Pivotal Trial

CureVac N.V. CVAC said results of the second interim analysis of CureVac's international Phase 2b/3 study of its first-generation vaccine candidate showed vaccine efficacy of 47% against COVID-19 disease of any severity.

The company also said the trial did not meet prespecified statistical success criteria.

The stock plunged 45.57% to $51.50 in after-hours trading.

FibroGen Announces Licensing Deal With HiFiBio For Preclinical Stage Immuno-oncology, Autoimmune Disease Assets

FibroGen, Inc. FGEN and HiFiBiO Therapeutics, a private clinical-stage biotherapeutics company with expertise in immune modulation and single cell science, announced a partnership covering three HiFiBiO programs — an exclusive license for the Galectin-9 Program and an exclusive option to the CXCR5 and CCR8 programs

"We are very pleased to add the HiFiBiO drug candidates to our pre-clinical development pipeline," said Enrique Conterno, CEO of FibroGen.

"With the addition of up to three programs in the immuno-oncology and autoimmune space, we have the potential to transform our early development pipeline."

Under the terms of the agreement, FibroGen will make a $25-million upfront payment to HiFiBiO, as well as payments upon option exercise. In addition, HiFiBiO may receive up to a total of an additional $1.1 billion in future option, clinical, regulatory, and commercial milestone payments across all three programs. HiFiBiO will also be eligible to receive royalties based upon worldwide net sales.

DermTech Announces 3 Key Senior Management Appointments

DermTech, Inc. DMTK announced the appointment of Loren Clarke as its chief medical officer. The company also appointed Ray Bassi to the role of VP, sales and Patrick Johnson to the role of VP, IT and digital systems.

In after-hours trading, the stock added 0.58% to $41.50.

Applied Therapeutics Gets Fast Track Designation For Drug to Treat Rare Metabolic Disorder

Applied Therapeutics, Inc. APLT announced that the FDA has granted Fast Track designation to AT-007 for the treatment of galactosemia, a rare metabolic disease.

The stock was climbing 8.46% to $24.88 in premarket trading Thursday.

On The Radar

PDUFA Date

The FDA is scheduled to rule on Orphazyme's NDA for Arimocolmol for the treatment of Niemann-Pick Disease Type C, a rare, relentlessly progressive, neurodegenerative disease. The PDUFA date has been set for Thursday, June 17. Arimocolmol was developed by CytRx Corporation CYTR and has been licensed to Orphazyme.

Offerings

Novan, Inc. NOVN announced a proposed underwritten public offering of its common stock. All shares to be sold in the Offering will be sold by Novan.

The stock slipped 11.05% to $12.32 in after-hours trading.

IPO

South San Francisco, California-based Lyell Immunopharma priced its initial public offering of 25 million shares of its common stock at $17, the midpoint of the estimated price range of $16 and $18. The shares of the oncology-focused company that uses T cells to cure solid tumors are expected to be listed on the Nasdaq under the ticker symbol "LYEL."

Verve Therapeutics, a biotech focused on developing single-course gene editing therapies to treat cardiovascular disease, priced its IPO of 14.036 million shares of its common stock at a price to the public of $19 per share. The gross proceeds to Verve from the offering are expected to be $266.7 million.

All of the shares are being offered by Verve. The shares are expected to begin trading on the Nasdaq under the ticker symbol "VERV."

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