Why BioCryst Pharmaceuticals Stock Is Sinking

 Shares of BioCryst Pharmaceuticals (BCRX -14.90%) are sinking today, down by 17.1% as of 11:09 a.m. ET. The big decline came after the drugmaker announced its fourth-quarter and full-year 2022 results before the market opened.

BioCryst reported Q4 revenue of $79.5 million, up from $47.2 million in the prior-year period. This result topped the consensus revenue estimate of $75.6 million.

The company posted a net loss in the fourth quarter of $71.5 million, or $0.38 per share, based on generally accepted accounting principles (GAAP). It posted a net loss of $17.8 million, or $0.10 per share, in Q4 2021. BioCryst recorded a non-GAAP loss of $73.6 million, or $0.40 per share. 

Analysts' consensus estimate was for a fourth-quarter 2022 net loss of $0.17 per share.

BioCryst also provided full-year 2023 guidance of net revenue for hereditary angioedema drug Orladeyo of at least $320 million. The company has another product, influenza antiviral therapy Rapivab, that generated net revenue of $8.7 million in the fourth quarter. However, it didn't give guidance for sales of Rapivab.

NASDAQ: BCRX

BioCryst Pharmaceuticals

Today's Change

(-14.90%) -$1.52

Current Price

$8.68

 BCRX

KEY DATA POINTS

Market Cap

$2B

Day's Range

$8.12 - $9.10

52wk Range

$7.61 - $18.60

Volume

12,758,396

Avg Vol

2,636,240

Gross Margin

-4.07%

Dividend Yield

N/A

There were three primary reasons behind BioCryst's Q4 earnings miss. The company's research and development expenses jumped, mainly due to increased investment in its complement inhibitor program. Selling, general, and administrative expenses rose significantly in large part because of the U.S. commercial launch of Orladeyo. Also, BioCryst's interest expense grew as a result of servicing its royalty and debt financing agreements.

Investors shouldn't focus too much on one disappointing quarter, though. BioCryst's future fortunes depend on the continued launch of Orladeyo and the company's pipeline progress.

Don't look for especially impressive first-quarter 2023 results from BioCryst. The company expects that sales for Orladeyo could even decline from Q4 2022 because of seasonal managed care reauthorizations. Over the longer term, though, BioCryst believes that Orladeyo could generate peak annual sales of $1 billion.

https://www.fool.com/investing/2023/02/21/why-biocryst-pharmaceuticals-stock-is-sinking-toda/

Chemomab OKd for Phase 2 Trial of CM-101 in Systemic Sclerosis

  Chemomab Therapeutics, Ltd. (Nasdaq: CMMB) (Chemomab), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced U.S. Food and Drug Administration (FDA) clearance of the company's Investigational New Drug (IND) Application to evaluate CM-101 in a Phase 2 trial in adults with systemic sclerosis (SSc).

CM-101 is a first-in-class monoclonal antibody designed to interfere with key biological pathways associated with SSc and other serious fibro-inflammatory diseases. In preclinical studies, CM-101 reduced inflammatory and fibrotic injury to the lung, skin and vasculature—organ systems often affected in SSc patients. In early clinical trials, CM-101 was well-tolerated, reducing fibrogenesis-related biomarkers and demonstrating anti-inflammatory effects in patients with severe lung inflammation, non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). CM-101 has been granted Orphan Drug designation by the FDA for SSc and for primary sclerosing cholangitis (PSC), a rare liver disease. The CM-101 Phase 2 SPRING trial in PSC patients is currently ongoing.

https://finance.yahoo.com/news/chemomab-announces-fda-clearance-investigational-120000601.html

Vir upped to Buy from Neutral by Goldman

 Target to $53 from $41

https://finviz.com/quote.ashx?t=VIR&ty=c&ta=1&p=d

Actinium cut to Market Perform by Blair

  from Outperform

https://finviz.com/quote.ashx?t=ATNM&p=d

Aileron Shelves Development On Chemoprotection Agent

 

• Aileron Therapeutics (NASDAQ: ALRN) announced that a review of initial data from its Phase 1b chemoprotection trial of ALRN-6924 in p53-mutated breast cancer showed severe neutropenia (Grade 4) and alopecia (hair loss).

• The primary endpoint of the Phase 1b open-label trial was evaluating ALRN-6924 in patients with breast cancer receiving neoadjuvant or adjuvant treatment with docetaxel, doxorubicin, and cyclophosphamide, or "TAC" chemotherapy, was the duration and incidence of severe neutropenia in cycle 1.

• The incidence of chemotherapy-induced alopecia (hair loss) was a secondary endpoint.

• Based on these findings, Aileron has decided to terminate the Phase 1b breast cancer trial and further development of ALRN-6924.

• Aileron also announced that it is exploring various strategic alternatives and has engaged Ladenburg Thalmann & Co Inc as a strategic advisor for this process.

• Aileron will reduce its remaining workforce from 9 to 3 full-time employees in the coming weeks. The company plans to retain the remaining employees to assist in executing the strategic alternatives review process.

https://finance.yahoo.com/news/aileron-therapeutics-shelves-development-chemoprotection-195027568.html

Why CVRx Stock Is Plunging

 

• CVRx Inc (NASDAQ: CVRX) announced the preliminary topline results of the BeAT-HF (Baroreflex Activation Therapy for Heart Failure) post-market randomized clinical trial.

• The BeAT-HF post-market trial assessed 323 patients suffering from heart failure with reduced ejection fraction.

• The patients were randomized into two groups, treatment with Barostim and guideline-directed medical therapy versus guideline-directed medical therapy alone.

• The primary endpoint was a composite of cardiovascular mortality and heart failure morbidity (specifically worsening heart failure events requiring treatment in the hospital or emergency department).

• The trial accrued 332 primary events and had a median follow-up of 3.7 years, corresponding to 1,037 patient-years.

• While the trial did not reach statistical significance on the primary endpoint, it did contain additional clinically meaningful prespecified analyses that favored Barostim, including:

• All-cause survival, free from LVAD and heart transplant,

• A hierarchical composite analysis of cardiovascular mortality, heart failure events, quality of life, and clinical stability analysis.

• In addition, the safety profile of Barostim and the symptomatic improvement at six months were durable through 24 months.

• Barostim, approved by the FDA, uses neuromodulation to improve the symptoms of patients with heart failure.

• Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery, activating the body's baroreflex, which in turn triggers an autonomic response to the heart.

https://finance.yahoo.com/news/why-cvrx-stock-plunging-today-161253229.html

Meihua in Deal to Build Technology Park and Medical R&D Center

 Meihua International Medical Technologies Co., Ltd. ("MHUA" or the "Company") (NASDAQ: MHUA), a reputable manufacturer and provider of Class I, II and III disposable medical devices with operating subsidiaries in China, today announced the Company, via its subsidiary company Hainan Guoxie Medical Technology Co. ("Hainan Guoxie"), has entered into cooperation agreement (the "Qionghai Agreement") with Qionghai City of Hainan Province to build technology park project. Hainan Guoxie also entered into cooperation agreement (the "Hope City Agreement") with Hainan Free Trade Port Boao Hope City ("Hope City") to build MHUA a medical research and development center in the Hope City.

Pursuant to the Qionghai Agreement, Hainan Guoxie plans to invest in the construction of a medical industrial park in Hainan Province for the will be focused on the development of minimally invasive interventional medical devices, new materials and surgical robotics technologies. Hainan Guoxie and Qionghai City government reached preliminary agreement to bid for the usage of nearly 574,080 sq ft of land around Hope City for the construction of a Contract Development and Manufacturing Organization (CDMO) medical industrial park. The Company anticipates making a more detailed public announcement of the land use right purchase information in about one month's time.

Pursuant to the Hope City Agreement, the planned MHUA medical R&D center will carry out the research and development of stem cell to human targeted therapies and rehabilitation training projects.

Presently, Hope City is the only special medical parkin China, which was approved by China State Council in 2013 and offers a series of special policies such as "licensed medical treatment, licensed research, licensed operation and licensed international medical technology exchange," and is a key project for the construction of the Hainan Free Trade Port. At present, there are 20 medical institutions involved in more than 10 projects under construction or planned in the pipeline, with 51 medical academicians forming the expert advisory team. In addition, Hope City has established cooperation with 30 of the top international pharmaceutical and medical devices enterprises, serving as one of the main channels for the importation of innovative products into China. The volume of licensed medicines and medical devices imported has exceeded 200 categories, effectively facilitating the advancement of medical technology, devices and medicine development in China to catch up with the international market.

https://finance.yahoo.com/news/meihua-international-medical-technologies-co-123000412.html