The Daily Biotech Pulse: Aldeyra Jumps Into COVID-19 Drug Fray, FDA Nod For Myriad's Companion Diagnostic Test

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 May 19)

• ADC Therapeutics SA ADCT (IPOed May 15)
• Allogene Therapeutics Inc ALLO
• Arcturus Therapeutics Ltd ARCT
• Bio-Rad Laboratories, Inc. BIO
• BioXcel Therapeutics Inc BTAI
• ChemoCentryx Inc CCXI
• Evoke Pharma Inc EVOK
• I-Mab ADR IMAB
• Imara Inc IMRA
• Intellia Therapeutics Inc NTLA
• Neurocrine Biosciences, Inc. NBIX
• Syndax Pharmaceuticals Inc SNDX
• Translate Bio Inc TBIO
• Twist Bioscience Corp TWST
• United Therapeutics Corporation UTHR
• VBI Vaccines Inc VBIV
• Vermillion, Inc. VRML
• Zai Lab Ltd ZLAB
• Zentalis Pharmaceuticals Inc ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 19)

• Lyra Therapeutics Inc LYRA (IPOed May 1)

Stocks In Focus

Myriad Announces FDA Approval For Companion Diagnostic Test For Prostate Cancer

Myriad Genetics, Inc. MYGN said the FDA approved the BRACAnalysis CDx test for use as a companion diagnostic by healthcare professionals to identify men with metastatic castration-resistant prostate cancer who are eligible for treatment with Lynparza.

Lynparza is a novel PARP inhibitor jointly developed and commercialized by AstraZeneca plc AZN and Merck & Co., Inc. MRK.

In pre-market trading Wednesday, Myriad shares were advancing 8.21% to $15.68.

Aldeyra To Advance Two Pipeline Assets Into Clinical Trials For COVID-19 Treatment

Aldeyra Therapeutics Inc ALDX announced the planned advancement of the investigational new HSP90 inhibitor ADX-1612 to clinical testing for COVID-19, and provided an update on ADX-629, a novel investigational RASP inhibitor in development for COVID-19 and other inflammatory diseases.

Aldeyra announced that ADX-1612 has demonstrated nanomolar potency similar to or greater than that of remdesivir in an in vitro model. Complementary to the nucleic acid inhibition mechanism of action of remdesivir and related antiviral compounds, ADX-1612 potentially leads to the inhibition of proteins associated with viral replication and infection, and thereby may enhance the activity of other antiviral drugs for the treatment of COVID-19. Pending FDA feedback, the company expects to file an IND the third quarter of 2020.

The company said ADX-629 has completed pre-IND discussions with the Pulmonary Division of the FDA, and an IND application is expected to be submitted in June 2020.

In pre-market trading, shares were up 23.70% to $4.75.

Eiger's NDA For Progeria Drug Accepted For Accelerated Review

Eiger Biopharmaceuticals Inc EIGR said the FDA accepted its NDA for an accelerated review of Zokinvy for treatment of Progeria and Progeroid Laminopathies. The PDUFA action date has been fixed for Nov. 20. The company noted that the FDA is not currently planning to hold an advisory committee meeting to discuss this application.

Related Link: These 6 Coronavirus Vaccine Candidates Are The Likeliest To Succeed, Says Morgan Stanley

Bio-Techne Announces Pact to Develop and Scale Up Serology Test Kits For Coronavirus

BIO-TECHNE Corp TECH and Kantaro Biosciences, the commercial affiliate of the Mount Sinai Health System in New York, announced a partnership to initiate scaled manufacturing and distribution of testing kits based on the Mount Sinai-developed COVID-19 serology test.

Bio-Techne said it has partnered with Kantaro to develop a test kit based on the Mount Sinai test and to scale up, manufacture, sell and distribute these kits. Initial kit production capacity is expected to enable laboratories to conduct in excess of 10 million tests monthly in July, scaling to higher capacity in subsequent months..

Offerings

Ocular Therapeutix Inc OCUL said it has commenced an underwritten public offering of its common stock. All of the shares in the offering are to be sold by the company. The company also said the offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

The stock fell 4.65% to $6.15 in after-hours trading.

Medigus Ltd. MDGS said it has priced its underwritten public offering of 3.33 million ADSs at a price of $1.50 per ADS. Each pre-funded warrant that allows purchase of one ADS is priced at $1.499 per pre-funded warrant. The company noted that the pre-funded warrants are exercisable at any time after the date of issuance upon payment of the exercise price of $0.001 per ADS.

The stock slipped 10.24% to $2.63 in after-hours trading.

VolitionRX Ltd VNRX said it intends to offer and sell shares of its common stock in an underwritten public offering. All the shares are being offered by the company.

In after-hours trading, the stock fell 7.30% to $2.92.

On The Radar

Earnings

Mediwound Ltd MDWD (before the market open)
China Biologic Products Holdings Inc CBPO (after the close)
Cumberland Pharmaceuticals, Inc. CPIX (after the close)