The Daily Biotech Pulse: FDA Nod For Astellas, Seagen, Gilead Get Positive Regulatory Tidings From Europe, 3 IPOs

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 March 25)

• Cellect Biotechnology Ltd. (NASDAQ: APOP) ( announced a reverse merger)

• GenMark Diagnostics, Inc. (NASDAQ: GNMK) (Roche Holding AG (OTC: RHHBY) commenced tender offer to buy the diagnostic company)

• Ibere Pharmaceuticals (NYSE: IBER-UN)

• ProQR Therapeutics N.V. (NASDAQ: PRQR) (follow-through buying from a positive readout from Wednesday)

• Prothena Corporation plc (NASDAQ: PRTA)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 25)

• Assembly Biosciences, Inc. (NASDAQ: ASMB)

• Avidity Biosciences, Inc. (NASDAQ: RNA)

• Biofrontera AG (NASDAQ: BFRA)

• Biophytis SA (NASDAQ: BPTS)

• Calithera Biosciences, Inc. (NASDAQ: CALA)

• Concert Pharmaceuticals, Inc. (NASDAQ: CNCE)

• ContraFect Corporation CFRX)

• Connect Biopharma Holdings Limited (NASDAQ: CNTB) (IPOed Friday)

• Decibel Therapeutics, Inc. (NASDAQ: DBTX)

• Epizyme, Inc. (NASDAQ: EPZM)

• Evaxion Biotech A/S (NASDAQ: EVAX)

• Evofem Biosciences, Inc. (NASDAQ: EVFM) (priced a common stock offering)

• Forma Therapeutics Holdings, Inc. (NASDAQ: FMTX)

• Fusion Pharmaceuticals Inc. (NASDAQ: FUSN)

• Galapagos NV (NASDAQ: GLPG)

• Galecto, Inc. (NASDAQ: GLTO)

• Gracell Biotechnologies Inc. (NASDAQ: GRCL)

• IMARA Inc. (NASDAQ: IMRA)

• Inhibikase Therapeutics, Inc. (NASDAQ: IKT)

• Instil Bio, Inc. (NASDAQ: TIL)

• Ionis Pharmaceuticals, Inc. (NASDAQ: IONS)

• Karyopharm Therapeutics Inc. (NASDAQ: KPTI)

• Longeveron Inc. (NASDAQ: LGVN)

• MorphoSys AG (NASDAQ: MOR)

• Metacrine, Inc. (NASDAQ: MTCR)

• Odonate Therapeutics, Inc. (NASDAQ: ODT)

• Olema Pharmaceuticals, Inc. (NASDAQ: OLMA)

• Oncorus, Inc. (NASDAQ: ONCR)

• Pharming Group N.V. (NASDAQ: PHAR)

• Prometheus Biosciences, Inc. (NASDAQ: RXDX)

• Sarepta Therapeutics, Inc. (NASDAQ: SRPT)

• Sigilon Therapeutics, Inc. (NASDAQ: SGTX)

• Soleno Therapeutics, Inc. (NASDAQ: SLNO)

• Spruce Biosciences, Inc. (NASDAQ: SPRB)

• Talis Biomedical Corporation (NASDAQ: TLIS)

• Universe Pharmaceuticals INC (NASDAQ: UPC)

• Vallon Pharmaceuticals, Inc. (NASDAQ: VLON)

• Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX)

• Voyager Therapeutics, Inc. (NASDAQ: VYGR)

Stocks In Focus Astellas Gets Label Expansion For Bladder Dysfunction Drug

Story continues

Astellas Pharma Inc. (OTC: ALPMY) said the Food and Drug Administration approved a new indication for Myrbetriq and Myrbetriq Granules to treat a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients.

Gilead’ Breast Cancer Drug Application Validated By European Regulator

Gilead Sciences, Inc. (NASDAQ: GILD) announced that the European Medicines Agency validated the marketing authorization application for sacituzumab govitecan-hziy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer, who have received at least two prior therapies.

The MAA is now under accelerated review by the EMA, in recognition of the product being considered of major interest for public health and therapeutic innovation.

Sacituzumab govitecan-hziy is an antibody-drug conjugate that came into Gilead’s stable through its acquisition of Immunomedics.

Seagan, Astellas Announce EMA Acceptance of Regulatory Application For Cancer Antibody-drug Conjugate

Seagen Inc. (NASDAQ: SGEN) and Astellas announced the EMA accepted the MAA for enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received prior treatments. If approved, enfortumab vedotin would be the first antibody-drug conjugate available in the European Union for people living with urothelial cancer, the companies said.

Seagen shares were adding 2.83% to $143.22 in premarket trading Friday.

Earnings

Phio Pharmaceuticals Corp. (NASDAQ: PHIO) said the loss narrowed from $19.33 per share in 2019 to $1.92 per share in 2020, in line with the consensus estimate.

The stock rose 7.30% to $2.94 in after-hours trading.

BIOLASE, Inc. (NASDAQ: BIOL) reported fourth-quarter revenues of $8.52 million, down 16.3% year-over-year. The loss per share, however, narrowed from 13 cents to 7 cents. Analysts estimated a narrower loss of 4 cents per share.

The stock was down 3.83% to 92.3 cents in premarket trading Friday.

Athersys, Inc.’s (NASDAQ: ATHX) fourth-quarter revenues increased from $0.3 million in 2019 to $1.3 million in 2020. The loss per share, though widening from 6 cents to 11 cents, was in line with the consensus estimate.

In premarket trading Friday, Athersys shares were advancing 4.60% to $1.82.

Vivos Therapeutics, Inc. (NASDA: VVOS) said its fourth-quarter revenues climbed from $3.1 million in 2019 to $3.3 million in 2020. The net loss per share widened from $2.6 million to $6.2 million.

The stock was gaining 9.65% to $7.50 in premarket trading Friday.

On The Radar IPOs

Design Therapeutics, Inc., a biotech developing a platform of gene-targeted chimera small molecules for the treatment of serious degenerative disorders caused by inherited nucleotide repeat expansions, priced its initial public offering of 12 million shares of its common stock at $20 per share. The gross proceeds from the offering are expected to be $240 million.

The shares are expected to begin trading on the Nasdaq under the ticker symbol DSGN.

Edgewise Therapeutics, Inc. priced its IPO of 11 million shares at a price of $16 per share, for raising gross proceeds of $176 million. Edgewise is a clinical-stage biopharma focused on developing orally bioavailable, small molecule therapies for rare muscle disorders.

The shares will begin trading on the Nasdaq under the ticker symbol EWTX.

Ikena Oncology, Inc., a targeted oncology company focused on developing cancer therapies targeting key signaling pathways, priced its IPO of 7.8125 million shares of common stock at $16 per share. The shares are expected to begin trading on the Nasdaq under the ticker symbol IKNA.

The gross proceeds of the offering are expected to be $125 million.

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