Calithera to Discontinue KEAPSAKE Clinical Trial

 KEAPSAKE interim analysis demonstrated lack of clinical benefit among patients treated with telaglenastat

--Company will focus on advancing newly acquired targeted oncology compounds sapanisertib and mivavotinib, as well as the ongoing trial of CB-280 for the treatment of cystic fibrosis

Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision oncology biopharmaceutical company, announced today the decision to terminate its phase 2 KEAPSAKE clinical trial based on a lack of clinical benefit observed in patients treated with telaglenastat in an interim analysis.

“We are disappointed in this outcome for the KEAPSAKE trial, but it was a well-run study with an interim analysis that gave us an answer to an important clinical question. We also want to express our sincere gratitude to the patients who participated in the trial and their families, as well as the physicians who served as investigators for the trial and their site staff,” said Susan Molineaux, PhD, chief executive officer of Calithera. “We remain committed to patients with difficult-to-treat cancers and will continue to advance our investigational targeted therapies for biomarker-specific patient populations. Our near-term clinical development plans include leveraging our clinical and biomarker expertise in the KEAP1/NRF2 pathway in the development of our mTORC1/2 inhibitor sapanisertib in squamous non-small cell lung cancer, as well as advancing the development of our SYK inhibitor mivavotinib in specific biomarker-defined populations of diffuse large B-cell lymphoma. In addition, we are continuing the development of our arginase inhibitor CB-280 for the treatment of cystic fibrosis.”

The phase 2 randomized, placebo-controlled, double-blind KEAPSAKE study was designed to evaluate the safety and anti-tumor activity of telaglenastat plus standard-of-care chemoimmunotherapy as front-line therapy among patients with stage IV non-squamous non-small cell lung cancer (NSCLC) whose tumors have a KEAP1 or NRF2 mutation. At the time of unblinding on October 27, 2021, there were 40 patients randomized. The available efficacy data at unblinding, including investigator-assessed progression-free survival (PFS), did not demonstrate clinical benefit, and analysis of the data led to the conclusion that there was a very low probability for the study to achieve a positive result. No difference in safety profile was seen between the two arms. The company has communicated these findings to the U.S. Food & Drug Administration (FDA) and has voluntarily discontinued the phase 2 study with agreement from members of the KEAPSAKE Steering Committee. Calithera has no plans to continue the development of telaglenastat at this time. Calithera estimates the cost savings resulting from the discontinuation of this trial will be $10-15 million.

https://finance.yahoo.com/news/calithera-biosciences-announces-decision-discontinue-110000111.html

Deciphera GI tumor therapy misses primary endpoint

 – Study Did Not Achieve Primary Efficacy Endpoint of Improved Progression-Free Survival Versus Standard of Care Sunitinib in Patients with Second-line GIST –

– Conference Call to be Held Today at 8:00 AM ET –

Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, November 5, 2021 at 8:00 AM ET. To access the live call by phone please dial (866) 930-5479 (domestic) or (409) 216-0603 (international); the conference ID is 3072405. A live audio webcast of the event may also be accessed through the "Investors" section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

https://finance.yahoo.com/news/deciphera-pharmaceuticals-announces-top-line-110000876.html

Apollo Medical ups full year guidance

 Guidance:

ApolloMed is raising its full-year 2021 guidance, previously disclosed on August 5, 2021, as a result of its continued organic growth and increased risk pool settlements and incentives revenue as a result of reduced utilization at ApolloMed's partner hospitals in 2020 during the COVID-19 pandemic and a shared savings settlement of $21.8 million from ApolloMed's participation in an Accountable Care Organization ("ACO") for the 2020 performance year. Net income and EBITDA include the impact of Allied Physicians of California, a Professional Medical Corporation's ("APC") investment in a payor partner, which completed an initial public offering to become a publicly traded company in June 2021. As APC's investment is an excluded asset solely for the benefit of APC and its shareholders, any gains or losses as a result of this investment do not affect the net income attributable to ApolloMed and adjusted EBITDA attributable to ApolloMed. The November 4, 2021 revised net income and EBITDA guidance ranges assume a stock price of the payor partner of $8.49. These assumptions are based on the Company's existing business, current view of existing market conditions, and assumptions for the year ending December 31, 2021.

($ in millions, except per share information)	2021 Guidance Range								2021 Guidance Range
	(as of August 5, 2021)								(as of November 4, 2021)
	Low				High				Low				High
Total revenue	$	700.0			$	720.0			$	751.5			$	758.5
Net income	$	56.0			$	66.0			$	81.0			$	83.5
Net income attributable to ApolloMed	$	48.0			$	58.0			$	71.5			$	73.5
Earnings per share - diluted	*				*				$	1.58			$	1.62
EBITDA	$	100.0			$	119.0			$	139.0			$	143.0
Adjusted EBITDA	$	120.5			$	130.5			$	168.5			$	170.5
*Range was not previously provided as of August 5, 2021.

See "Guidance Reconciliation of Net Income to EBITDA and Adjusted EBITDA" and "Use of Non-GAAP Financial Measures" below for additional information. There can be no assurance that actual amounts will not be materially higher or lower than these expectations. See "Forward-Looking Statements" below for additional information.

Management Commentary:
Kenneth Sim, M.D., Executive Chairman of ApolloMed, stated, "We delivered a strong third quarter, achieving 26% growth on the top line and 105% growth in net income attributable to ApolloMed primarily as a result of organic membership growth in our existing IPAs and increased risk pool settlements and incentives revenue due to decreased utilization at our partner hospitals during the height of the pandemic and the shared savings settlement from our participation in an ACO model for performance year 2020. Our ACO generated $57.7 million in gross savings during the 2020 performance year, which is the highest dollar amount saved out of all 37 ACOs in the country by a margin of over $18 million. This incredible performance is a further testament to the results being driven by our proprietary tech platform, which has increasingly improved the ability of our physicians to deliver high-quality care in a cost-effective manner over the past year. As a result of these trends and our continued organic growth, we are pleased to once again raise our guidance for the full-year 2021. Today we announced the appointment of Brandon Sim to the role of Co-CEO in what we felt was a natural transition given his growing leadership role in key areas of our business since he joined ApolloMed in 2019. The management team is well positioned with Brandon at its helm. We believe his background and ability to consistently deliver tangible results will serve the Company well in the years to come."

Brandon Sim, Co-CEO of ApolloMed, added, "I am excited to have this opportunity to continue the stellar work we have been doing here at ApolloMed over the past two years. During the third quarter, we closed a few previously announced transactions, specifically the CAIPA MSO strategic alliance and investment and the acquisition of controlling interests in Access Primary Care Medical Group and Sun Clinical Laboratories (Sun Labs). Earlier this week, we announced the signing of an agreement whereby our affiliate has committed to purchasing the remaining equity interests in DMG, a complete outpatient imaging center that has been serving patients in the San Gabriel Valley area of southern California since 1984. Our affiliate currently owns 40% of DMG and has committed to purchasing the remaining 60% within the next three years. We are pleased to be expanding upon our partnership with DMG and look forward to continuing to enhance DMG's commitment to superior patient experience while exploring potential opportunities to bring its service offerings to new markets. Our platform and growth strategy have driven the incredible results we have been able to achieve in the first nine months of 2021, and we look forward to closing the year with a strong fourth quarter."

https://finance.yahoo.com/news/apollo-medical-holdings-inc-reports-200600838.html

Sarepta upped to Overweight from Neutral by JPMorgan

 Target $130

https://finviz.com/quote.ashx?t=srpt

Novo Nordisk Wegovy shows significant, sustained weight loss in 2-year obesity study

 

• The STEP 5 trial demonstrated an average weight loss of 15.2% with Wegovy™ at 104-weeks when used with a reduced calorie meal plan and increased physical activity vs. 2.6% with placebo

• The trial also showed that 77.1% of study participants who received Wegovy™ lost at least 5% of their body weight, compared to 34.4% of those who received placebo

Results from the STEP 5 phase 3b trial, presented today at the ObesityWeek® 2021 interactive congress, showed that adults treated with Wegovy™ (semaglutide 2.4 mg injection) achieved significant and sustained weight loss over the two-year study period. The STEP 5 trial investigated Wegovy™ vs. placebo, both used with a reduced calorie meal plan and increased physical activity for the treatment of obesity (BMI ≥30 kg/m2) or overweight (BMI ≥27 kg/ m2) in 304 adults with at least one weight-related comorbidity for 104 weeks (two years).1

In the STEP 5 trial, results showed that Wegovy™ used with a reduced calorie meal plan and increased physical activity significantly reduced body weight from baseline to week 104 compared to placebo (-15.2% vs. -2.6%, estimated treatment difference: -12.6% -points [95% CI: -15.3, -9.8]; p<0.0001)1. The study also demonstrated that adults with overweight or obesity were more likely to lose at least 5% of their body weight with Wegovy™ vs. placebo (77.1% vs. 34.4%; p<0.0001).

“People with obesity try on average seven times to lose weight before seeking medical care. Once weight is lost, however, it all too often comes back, which is why it is critically important to find options to help people living with obesity lose weight and keep it off,” said W. Timothy Garvey, MD, Professor of Medicine, Department of Nutrition Sciences at the University of Alabama in Birmingham. “Results from the STEP 5 clinical trial demonstrated that adults with obesity were able to lose weight whilst taking Wegovy™ and maintain the weight loss at two years, which can help us better treat and manage obesity as a chronic disease.”

https://finance.yahoo.com/news/wegovy-demonstrated-significant-sustained-weight-124700454.html

Endo Reports Third Quarter, Ups 2021 Financial Guidance

 Endo International plc (NASDAQ: ENDP) today reported financial results for the third-quarter ended September 30, 2021.

"We delivered strong third-quarter results driven by outstanding execution across all of our businesses. As a result of our year-to-date performance and our expectations for the remainder of 2021, we are raising our full-year 2021 financial guidance," said Blaise Coleman, President and Chief Executive Officer at Endo. "Additionally, we are pleased with our progress against our strategic priorities including our efforts to expand and enhance our portfolio with the recent launch of varenicline tablets, the only available FDA approved generic version of Chantix®, and the continued positive market response to QWO®."

2021 FINANCIAL GUIDANCE

Endo is updating its financial guidance for the full-year ending December 31, 2021 by raising the expected ranges regarding revenues, adjusted diluted net income per share from continuing operations and adjusted EBITDA. The guidance below contemplates a range of potential outcomes that reflect uncertainties in certain key assumptions including, among other things, uncertainties related to the COVID-19 pandemic. These statements are forward-looking, and actual results may differ materially from Endo's expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements."

	Full-Year 2021
	Prior		Current
Total Revenues, Net	$2.73B - $2.79B		$2.90B - $2.94B
Adjusted EBITDA	$1.23B - $1.28B		$1.40B - $1.42B
Adjusted Diluted Net Income per Share from Continuing Operations	$2.15 - $2.30		$2.80 - $2.85
Assumptions:
Adjusted Gross Margin	~70.0% - 71.0%		~71.5%
Adjusted Operating Expenses as a Percentage of Total Revenues, Net	~28.5%		~26.5%
Adjusted Interest Expense	~$560M		~$560M
Adjusted Effective Tax Rate	~11.0% - 12.0%		~13.0%
Adjusted Diluted Weighted Average Shares	~239M		~236M

https://finance.yahoo.com/news/endo-reports-third-quarter-2021-201500240.html

Emergent slumps as U.S. terminates COVID-19 vaccine manufacturing deal

 Shares of Emergent BioSolutions Inc tumbled 15% on Friday, following the termination of a U.S. government contract to reserve capacity and expand manufacturing of third-party COVID-19 vaccines at its sites.

The contract manufacturer has come under regulatory fire after an accidental mix-up of ingredients ruined about 15 million doses of Johnson & Johnson's COVID-19 vaccine and prompted the U.S. Food and Drug Administration to halt operations at its Baltimore plant earlier this year.

The modification of terms with the U.S. Department of Health and Human Services will reduce the contract's value to $470.9 million from $650.8 million, Emergent said in a regulatory filing late on Thursday.

Emergent said in late July it would resume production of J&J's vaccine at the plant following additional FDA reviews.

The termination of contract with the U.S. government further decreases revenue for Emergent's deteriorating contract drug manufacturing business, Cowen analyst Boris Peaker said in a note.

The material manufactured for the J&J vaccine at the Baltimore plant prior to the April shutdown and awaiting FDA approval could be enough to produce as many as 50 million shots, Reuters reported last month.

Emergent said on Thursday it was expecting to continue supporting J&J out of its Bayview site.

Emergent shares have fallen 41% this year up to Thursday's close.

https://finance.yahoo.com/news/emergent-slumps-u-terminates-covid-113116337.html