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 Jan. 6)
- 9 Meters Biopharma Inc NMTR
- AngioDynamics, Inc. ANGO
- Atea Pharmaceuticals, Inc. AVIR
- AxoGen, Inc Common Stock AXGN
- Axonics Modulation Technologies Inc AXNX
- BIO-TECHNE Corp TECH
- Endo International PLC ENDP
- Eyenovia Inc EYEN
- Fulgent Genetics Inc FLGT
- Genetron Holdings Ltd – ADR GTH (announced an exclusive strategic partnership agreement for screening for kidney cancer)
- Glaukos Corp GKOS
- Globus Medical Inc GMED
- Guardion Health Sciences Inc GHSI
- Hologic, Inc. HOLX
- I-Mab ADR IMAB
- Johnson & Johnson JNJ
- LeMaitre Vascular Inc LMAT
- Masimo Corporation MASI
- Otonomy Inc OTIC
- Pacific Biosciences of California Inc PACB
- Praxis Precision Medicines Inc PRAX
- Radius Health Inc RDUS (announced a definitive agreement to acquire rights to Benuvia Therapeutics' synthetic cannabidiol oral solution)
- Shockwave Medical Inc SWAV
- United Therapeutics Corporation UTHR
- Vericel Corp VCEL
- Zai Lab Ltd – ADR ZLAB
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Jan. 6)
- AbCellera Biologics Inc ABCL
- PainReform Ltd PRFX
Stocks In Focus
CureVac To Collaborate With Bayer On COVID-19 Vaccine Development, Distribution
CureVac BV CVAC announced an agreement with German chemicals company Bayer AG BAYRY under which Bayer will support the development, supply and key territory operations of the former's COVID-19 vaccine candidate CVnCoV.
Based on the collaboration agreement, CureVac will be the marketing authorization holder for the product, while Bayer will support CureVac with country operations within the European Union and selected additional markets.
Bayer holds further options to become marketing authorization holder in other markets outside of Europe.
In premarket trading Thursday, CureVac shares were surging 15.14% to $100.
DBV To File As Domestic Issuer In US, Announces Approval For Global Restructuring Plan
DBV Technologies ADR Representing 0.5 Ord Shs DBVT said it now qualifies as a U.S. domestic issuer rather than a foreign private issuer in the U.S., and accordingly will need to file with the SEC periodic reports and registration statements on U.S. domestic issuer forms.
The company also announced approval for the global restructuring plan it unveiled in June 2020 to provide operational latitude to progress the clinical development and regulatory review of investigational Viaskin Peanut in the U.S. and the European Union. The full rollout of the restructuring plan, the company said, will result in a reduction of more than 200 jobs, resulting in a remaining global team of 90 individuals.
Based on assumptions regarding the progress of its regulatory dossier and in light of the final approval of the plan, DBV expects the cost reduction efforts to significantly extend its cash runway to the second half of 2022.
The stock was slipping 11.33% to $3.21 in premarket trading Thursday following a 27.46% jump Wednesday.
Argenx Out-Licenses Rights For Efgartigimod To Zai Lab In China
Argenx SE – ADR ARGX and Zai Lab announced an exclusive license agreement for the development and commercialization of efgartigimod in Greater China, including mainland China, Hong Kong, Taiwan and Macau.
A regulatory application for the approval of efgartigimod in generalized myasthenia gravis is pending before the FDA.
Argenx will receive $175 million in collaboration payments, comprised of a $75-million upfront payment in the form of 568,182 newly issued Zai Lab shares calculated at a price of $132 per share; $75 million as a guaranteed non-creditable, non-refundable development cost-sharing payment; and an additional $25-million milestone payment upon approval of efgartigimod in the U.S.
Additionally, Argenx is also eligible to receive tiered royalties in the mid-teen to low-20s on a percentage basis based on annual net sales of efgartigimod in Greater China.
Argenx shares were down 1.1% at $280.03 premarket Thursday.
Chiasma Guides To Below-Consensus Revenue For 2020
Issuing a corporate update, Chiasma Inc CHMA said it expects preliminary net revenues of $900,000 to $1.1 million for 2020. This is below the $1.39-million consensus estimate.
The company noted that Mycapssa, which became commercially available in the U.S. late in the third quarter following approval, is getting positive feedback from endocrinologists and patients, supporting the company's goal of ultimately becoming the standard of pharmacological care in acromegaly.
Coverage by Mycapssa by multiple payers, insuring about 150 million lives, provides for a solid foundation for its uptake in 2021, the company said.
Chiasma is planning a regulatory filing with the European Medicines Agency in mid-2021.
For 2021, the company expects operating expenses in a range of $80 million to $90 million.
In after-hours trading, the stock was up 1.88% to $4.34.
Amarin Guides FY20 Revenues Below Consensus
Ahead of a presentation at the JPMorgan Healthcare Conference, Amarin Corporation plc AMRN issued a corporate update, stating that it expects full-year revenue of about $610 million, a 42% year-over-year increase. This trailed the consensus estimate of $619.19 million.
The stock was trading 3.1% higher to $5.32 premarket Thursday.
Pfizer Commences Late-Stage Study Of DMD Gene Therapy
Pfizer Inc. PFE said the first participant has been dosed in the Phase 3 CIFFREO study, which will evaluate the efficacy and safety of investigational gene therapy candidate PF-06939926 in boys with Duchenne muscular dystrophy. The CIFFREO trial is expected to enroll 99 ambulatory male patients, ages 4 through 7, across 55 clinical trial sites in 15 countries, the company said.
The stock was edging up 0.43% to $37.03 in premarket trading Thursday.
Xencor Enters Into Cancer R&D Collaboration With MD Anderson
Xencor Inc XNCR and the University of Texas MD Anderson Cancer Center announced a strategic R&D collaboration and commercialization agreement to develop novel CD3 bispecific antibody therapeutics for the potential treatment of patients with cancer.
MD Anderson will work to identify and develop potential antibodies, collaborating with Xencor to apply its XmAb bispecific technology to create therapeutic candidates, and then conduct and fund all preclinical activities to advance candidates toward clinical studies.
Xencor has certain exclusive options to license worldwide rights to develop and commercialize potential new medicines arising from the research collaboration. For programs not licensed by Xencor, Xencor will receive a portion of future payments received by MD Anderson. Xencor and MD Anderson are entering into the collaboration with two predetermined, undisclosed antibody candidates.
Morphosys Appoints Sangamo Executive As CFO
Morphosys Ag MOR announced the appointment of Sung Lee as CFO effective Feb. 2, succeeding Jens Holstein, who stepped down in December. Lee will be based in Planegg, Germany.
Lee is currently working as the CFO of Sangamo Therapeutics Inc SGMO.
Immutep Completes Enrollment In Midstage Study Of Lead Drug In Head, Neck Cancer
Immutep ADS Representing 10 Ord Shs IMMP said it has enrolled and safely dosed the last patient for stage 2 of Part C of its TACTI-002 Phase 2 study, which is evaluating its lead product candidate, eftilagimod alpha, in combination with Merck & Co., Inc.'s MRK Keytruda, in second-line head and neck squamous cell carcinoma patients.
The company said it expects to report more data from TACTI-002 in the first half of 2021.
The stock was rising 3.52% premarket to $3.23.
Harpoon Therapeutics Inc HARP priced its underwritten public offering of 5.882 million shares of its common stock at $17 per share for raising gross proceeds of about $100 million. The offering is expected to close on Jan. 11.
The stock was down 4.67% premarket at $17.56.
DermTech Inc DMTK priced its previously announced underwritten public offering of 4.237 million shares of its common stock at $29.50 per share. The company expects to raise gross proceeds of about $125 million from the offering.
The company said it intends to use the net proceeds from the offering to fund further commercialization of its clinical commercial tests, accelerate pipeline development and for general corporate purposes, including working capital and other general and administrative purposes.
The stock was down 4.65% premarket to $32.98.
Addex Therapeutics ADR ADXN priced its underwritten global offering of 6 million registered shares at a public offering price of about 1.47 Swiss francs per share or $10 per ADS. Each ADS represents the right to receive six shares of Addex. The aggregate gross proceeds from the offering are expected to be $10 million.
Regenxbio Inc RGNX said it intends to sell, subject to market conditions, $175 million of its common stock in an underwritten public offering.
The stock was down 0.12% premarket at $48.62.
Celyad Oncology SA ADR CYAD said it has entered into a committed equity purchase agreement for up to $40 million with Lincoln Park Capital Fund, a Chicago-based institutional investor.
On The Radar
Aldeyra Therapeutics Inc ALDX is scheduled to discuss top-line symptom, redness and Schirmer's test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial in patients with dry eye disease.
AngioDynamics (before the market open)
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