The Daily Biotech Pulse: Aerpio Reviews Strategic Options, Hologic Goes Shopping

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. 5)

• Curis, Inc. CRIS
• Endo International PLC ENDP
• Fulgent Genetics Inc FLGT
• Genmab 10 Sponsored ADR Ord Shs GMAB
• \I-Mab ADR IMAB
• Jaguar Health Inc JAGX
• Johnson & Johnson JNJ
• LeMaitre Vascular Inc LMAT
• Oncorus Inc ONCR
• Organogenesis Holdings Inc ORGO
• Pulse Biosciences Inc PLSE
• Renalytix AI PLC RNLX (announced a partnership with Davita Inc DVA aimed at slowing disease progression and improving health outcomes in with chronic kidney disease patients)
• Shockwave Medical Inc SWAV
• Silence Therapeutics ADR Representing 3 Ord Shs SLN
• United Therapeutics Corporation UTHR
• Vincera Pharma Inc VINC

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Jan. 5)

• 4D Molecular Therapeutics Inc FDMT

Stocks In Focus

Aerpio To Review Strategic Alternatives; Reports Positive Phase 2 Results For Glaucoma Treatment

Aerpio Pharmaceuticals Inc ARPO said it has initiated a process to explore and review a range of strategic alternatives focused on maximizing stockholder value.

The company also announced topline results from a Phase 2 study of razuprotafib in glaucoma, showing that patients treated with razuprotafib twice daily plus latanoprost demonstrated a statistically significant change from baseline in diurnal mean interocular pressure at Day 28 of study, compared to those treated with latanoprost monotherapy.

Further analysis showed the combo had a larger IOP reduction after longer duration dosing and produced larger IOP reductions in patients with higher starting IOP.

The stock rallied 12.15% to $1.20 in after-hours trading.

Hologic To Buy Privately-held Cancer Diagnostics Company For $230M

Hologic, Inc. HOLX announced an agreement to acquire Biotheranostics, Inc., a privately held, commercial-stage company that provides molecular diagnostic tests for breast and metastatic cancers, for approximately $230 million, subject to working capital and other customary closing adjustments.

"Acquiring Biotheranostics enables us to jump-start our entry into a large, fast-growing oncology adjacency that fits perfectly with our broader corporate focus and passion for women's health," said Kevin Thornal, Hologic's Division President, Diagnostics.

Myriad to Review Strategic Alternatives For Autoimmune Business, Refocuses Efforts on High-growth International Markets

Following completion of its strategic business unit and products review, Myriad Genetics, Inc. MYGN said it's pursuing strategic alternatives for our Autoimmune business and realigning its International business unit to streamline operations, reduce complexity and cost, and concentrate on our biggest growth opportunities.

The restructuring of International operations will focus direct selling efforts on high-growth market opportunities in Germany, France, and Japan, while the remaining international markets will be served through alternative business models, including authorized distributor partnerships.

This realignment, the company said, will lead to about $5 million in incremental cost savings upon full implementation.

AIM ImmunoTech Commences Study of Treatment For Post-COVID-19 Fatigue-like Symptoms

AIM ImmunoTech Inc AIM said it has dosed its first COVID-19 "Long Hauler" patient with the drug Ampligen, marking a significant milestone in its efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are in the process of being enrolled.

TransEnterix Preannounces Above-consensus Q4, FY20 Revenues

Transenterix Inc TRXC said it expects revenues for the fourth quarter to be about $1.1 million and full-year revenues to be $3 million to $3.2 million. This surrounded the consensus estimates for $1.04 million for the quarter and $3.11 million for 2020.

Stealth's Pre-NDA Meeting Request For Cardiomyopathy Treatment Granted By FDA

Stealth BioTherapeutics Corp MITO said its plan to meet with the FDA's Division of Cardiology and Nephrology regarding its upcoming NDA submission for elamipretide for the treatment of cardiomyopathy in Barth syndrome.

"We are encouraged by the agency's acceptance of our Pre-NDA meeting request," said Reenie McCarthy, CEO of Stealth.

"We view this upcoming meeting as an important next step toward our goal of bringing elamipretide to patients suffering from this ultra-rare disease and hope that it may also inform our future development efforts in other rare cardiomyopathies."

Illumina to Collaborate With Helix For Surveillance of Novel Strains of Coronavirus In U.S.

Illumina, Inc. ILMN announced a collaboration with Helix to augment national surveillance infrastructure in the U.S. to track the emergence and prevalence of novel strains of SARS-CoV-2 with support from the CDC. The combination of Illumina's sequencing technology and expertise and Helix's national COVID-19 testing footprint will significantly expand the country's existing surveillance efforts to detect and characterize emerging variants of SARS-CoV-2, the company said.

Nektar Announces Departure of Chief Medical Officer

Nektar Therapeutics NKTR announced the appointment of Brian Kotzin, as interim chief medical officer, Head of Development effective immediately. This follows the decision by the incumbent, Wei Lin, to leave the company to pursue another opportunity.

Offerings

NeoGenomics, Inc. NEO announced that it has commenced proposed underwritten public offerings of approximately $200 million worth of newly issued shares of common stock and $250 million worth of aggregate principal amount of convertible senior notes due 2028.

The stock ended down 4.81% to $ 52.20 in after-hours trading.

Eyegate Pharmaceuticals Inc EYEG said it has entered into a securities purchase agreement in connection with a private placement with an affiliate of Armistice Capital for aggregate gross proceeds of approximately $8 million.

On The Radar

Moderna Inc's MRNA coronavirus vaccine candidate will be reviewed by the European Medicines Agency's Committee For Medical Products For Human Use in a meeting. Although the regulator has given a deadline of Jan. 12 for making a decision regarding conditional approval for the vaccine in Europe, a verdict could come as early as Wednesday.