The Daily Biotech Pulse: Takeda Jumps Into The COVID-19 Fray, Exact Sciences Buys Cancer Diagnostics Companies

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 on March 3)

• Acceleron Pharma Inc XLRN
• BioMarin Pharmaceutical Inc. BMRN
• Fate Therapeutics Inc FATE (reacted to its fourth-quarter results)
• Forty Seven Inc FTSV
• IGM Biosciences Inc IGMS
• Inovio Pharmaceuticals Inc INO( announced an accelerated timeline for COVID-19 vaccine development)
• Repro-Med Systems, Inc. KRMD
• SpringWorks Therapeutics Inc SWTX
• Zynex Inc. ZYXI

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on March 3)

• ADDEX THERAPEUT/ADR ADXN
• Akorn, Inc. AKRX
• Aldeyra Therapeutics Inc ALDX
• ANI Pharmaceuticals Inc ANIP
• Evolus Inc EOLS
• EXACT Sciences Corporation EXAS
• HTG Molecular Diagnostics Inc HTGM
• Midatech Pharma PLC-ADR MTP(began trading on a reverse split adjusted basis)
• Mylan NV MYL
• Neuronetics Inc STIM(announced its fourth-quarter results)
• Passage Bio Inc PASG(IPOed last week)
• STRATA Skin Sciences Inc SSKN
• SurModics, Inc. SRDX
• Tetraphase Pharmaceuticals Inc TTPH
• TransMedics Group Inc TMDX(reported its fourth-quarter results)
• VIVUS, Inc. VVUS
• Xeris Pharmaceuticals Inc XERS

See Also: Attention Biotech Investors: Mark Your Calendar For These March PDUFA Dates

Stocks In Focus

Takeda To Develop COVID-19 Treatments

Takeda Pharmaceutical Co Ltd TAK said it is initiating the development of an anti-SARS-CoV-2 polyclonal hyperimmune globulin to treat high-risk individuals with the viral infection. Hyperimmune globulins are plasma-derived therapies that had previously proven its efficacy in treating severe acute viral respiratory infections.

The company added it is also studying its currently marketed and pipeline products to see whether they are effective treatments for infected patients.

Separately, the company said it has completed its previously announced sale of portfolio of select products to STADA for $660 million.

In pre-market trading Wednesday, Takeda shares were adding 3.94% to $18.20.

Vir, Alnylam Expands Collaboration To Develop siRNA Therapies For COVID-19

Vir Biotechnology Inc VIR and Alnylam Pharmaceuticals, Inc. ALNY announced an expansion to their existing collaboration to include the development and commercialization of RNAi therapeutics against COVID-19. The agreement provides for Vir using Alnylam's recent advances in lung delivery of novel conjugates of siRNA along with its infectious disease expertise to develop one or some siRNAs to treat COVID-19 and other coronaviruses as well.

In premarket trading Wednesday, Vir share were rallying 14.72% to $47 and Alnylam was edging up 0.41% to $111.88.

Mallinckrodt Reports Positive Outcome Analysis of Acthar Gel In Immune-mediated Diseases

Mallinckrodt PLC MNK announced findings from a retrospective medical record analysis, which assessed practice patterns and outcomes of Acthar Gel in the treatment of immune-mediated diseases rheumatoid arthritis, systemic lupus erythematosus and dermatomyositis/polymyositis, which showed across all the three patient populations, symptoms improved with Acthar Gel.

In premarket trading Wednesday, the shares were advancing 7.99% $3.38.

Acadia's Rett Syndrome Investigational Drug Gets Rare Pediatric Designation

ACADIA Pharmaceuticals Inc. ACAD and Neuren Pharma said the FDA has granted Rare Pediatric Disease designation to trofinetide for the treatment of Rett syndrome, a serious and rare neurological disorder.

Upon approval of a product with the designation, the sponsor is eligible to receive a Priority Review Voucher, which can be used to obtain FDA approval of an NDA for another product in an expedited period of six months.

Acadia shares were up 2.41% to $42.99 in after-hours trading.

Morphosys' Licensing Agreement With Incyte For Lymphoma Drug Gets Antitrust Clearance

Morphosys Ag MOR and Incyte Corporation INCY said their joint collaboration and license agreement for further development and global commercialization of Morphosys' investigational compound tafasitamab has received antitrust clearance and becomes effective Tuesday.

The regulatory milestone triggers a $750 million upfront payment by Incyte to Morphosys, and also Incyte's equity investment of $150 million into MorphoSys within the defined timelines.

The PDUFA date for the BLA for tafasitamab in combination with lenalidomide for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma is Aug. 30.

Ultragenyx CFO To Step Down

Ultragenyx Pharmaceutical Inc RARE said Shalini Sharp will step down as CFO and EVP, effective Sept. 2. The company said it will initiate a search for a successor.

Exact Sciences Buys Two Cancer Diagnostics Companies

Exact Sciences said it has completed its acquisition of Paradigm Diagnostics and Viomics, two privately held companies, which provide a differentiated late-stage therapy selection test and deep competencies in sequencing and biomarker discovery.

The company expects the acquisition to extend its lab testing and research and development capabilities.

J&J Makes Regulatory Submission For Approval of Multiple Sclerosis Drug In Europe

Johnson & Johnson's JNJ Janssen unit announced it submitted a Marketing Authorization Application to EMA, seeking approval for ponesimod for the treatment of adult patients with relapsing multiple sclerosis.

Earnings

DURECT Corporation DRRX reported fourth-quarter net revenues of $10.69 million compared to $3.63 million last year. The net loss per share narrowed from 5 cents to 2 cents, in line with the consensus estimate.

The stock jumped 12.21% to $1.93 in after-hours trading.

Menlo Therapeutics Inc's MNLO, which has agreed to be bought by Foamix Pharmaceuticals Ltd FOMX, reported a wider loss of 89 cents per share compared to the year-ago loss of 76 cents per share and the consensus loss estimate of 83 cents per share.

Updating on the pending merger, Menlo said it expects it to close March 9.

The stock jumped 23.64% to $3.40 in after-hours trading.

Voyager Therapeutics Inc VYGR reported fourth quarter revenues of $32.67 million compared to $2.01 million a year ago. The net loss per share narrowed from 77 cents to 34 cents. Analysts had estimated a loss of 81 cents per share. The company said it expects its cash reserves as well as receivables to be sufficient to meet its projected operating expenses and capex into mid-2022.

The stock gained 6.22% to $12.30 in after-hours trading.

Vivus reported fourth-quarter total revenues of $17.25 million and a loss of 61 cents per share, narrower than the 68 cents per share loss expected by analysts.

The stock rose 8.98% to $1.82 in after-hours trading.

Offerings

Zogenix, Inc. ZGNX said it has priced its underwritten public offering of 8.52 million shares at $23.50 per share. The company expects to raise gross proceeds of $200.2 million from the offering. The offering is expected to close on or about March 6.

The company said it expects to use the net proceeds for the potential commercialization of Fintepla for the treatment of Dravet syndrome, among other things.

The stock fell 3.69% to $24 in after-hours trading.

On The Radar

Earnings

• AMAG Pharmaceuticals, Inc. AMAG (before the market open)
• Recro Pharma Inc REPH (before the market open)
• PPD Inc PPD (before the market open)
• Axonics Modulation Technologies Inc AXNX (after the close)
• Orthopediatrics Corp KIDS (after the close)
• Opiant Pharmaceuticals Inc OPNT (after the close)