Nasdaq Stocks

Amgen announced on Jan. 29 that its experimental lung cancer drug, sotorasib, has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation in China.

The BTD designation was granted for patients with metastatic non-small cell lung cancer (NSLC) and who have received at least one systemic therapy before. The BTD means that in China, sotorasib could become the first targeted treatment for non-small cell lung cancer. The Center for Drug Evaluation is part of the National Medical Products Administration (NMPA).

According to Amgen (AMGN), non-small cell lung cancer is the most common form of lung cancer that accounts worldwide for 80% to 85% of all cases. This was the first BTD submission for the biopharma company in China under the company’s collaboration with BeiGene.

David M. Reese, EVP of R&D at Amgen commented, “Given that Breakthrough Therapy Designation is a new pathway in China, we are pleased to receive this designation for sotorasib. This designation underscores the importance of sotorasib and we look forward to working with regulatory authorities in China to bring the first potential targeted therapy to NSCLC patients with the KRAS G12C mutation.”

The Chinese drug authority’s approval comes as the company’s Phase 2 study for sotorasib showed positive results and the drug was found to be effective for NSLC. (See Amgen stock analysis on TipRanks)

On Jan. 29, Credit Suisse analyst Evan Seigerman reiterated a Buy rating and a price target of $280 on the stock.

Seigerman commented on the Phase 2 study of sotorasib, saying that “the ORR [overall response rate] of 37% is similar to the 35.3% reported in Phase 1 on an ‘all comers’ basis, and should be good enough to continue competing with Mirati’s ~45% for Adagrasib that was provided from pooled Phase 1/2 data (on an arguably modified ITT [intention to treat] basis).”

“We are encouraged that 3 patients experienced a complete response--suggesting deep responses in some patients. Safety continues to look acceptable with most treatment-related adverse events (TRAEs) classified as mild-to-moderate and no treatment related deaths.” Seigerman added.

The rest of the Street is cautiously optimistic about the stock with a Moderate Buy consensus rating. That’s based on 9 analysts recommending a Buy and 7 analysts suggesting a Hold. The average analyst price target of $270.17 implies 11.9% upside potential to current levels. Shares fell 2.5% to $241.43 on Jan. 29.

Related News:
Facebook’s Strong Advertising Revenues Fuel Blowout Quarter
Facebook’s CEO Reaches Out To Australian Lawmakers Over Proposed Law – Report
Perspecta To Be Snapped Up By Veritas For $7.1B; Shares Pop 9.7%

Colgate-Palmolive reported better-than-expected 4Q results, reflecting strong consumer demand for its products amid the COVID-19 pandemic.

However, shares of the consumer products company fell 1.5% on Friday after it said that “we expect high levels of uncertainty as we lap the benefits from pantry loading and other impacts of the COVID-19 pandemic. We also expect volatility in raw material and logistics costs and foreign exchange.”

Colgate-Palmolive’s (CL) 4Q earnings of $0.77 per share increased 5% year-over-year and topped analysts’ expectations by a penny. Sales grew 7.5% to $4.32 billion year-over-year and came in above the Street’s forecasts of $4.14 billion.

The company said that it maintained its global leadership in the toothpaste and manual toothbrush category with a market share of 39.8% and 31.1%, respectively, year-to-date. (See CL stock analysis on TipRanks)

For fiscal 2021, Colgate-Palmolive projects net sales to increase between 4% and 7% year-over-year. It forecasts adjusted EPS to grow in the mid-to-high single-digit range.

Ahead of its earnings release, Stifel Nicolaus analyst Mark Astrachan downgraded the stock to Hold from Buy and lowered the price target to $83 (6.4% upside potential) from $88.

In a note to investors, Astrachan wrote, “We think only modest near-term EPS upside coupled with valuation in line with historical averages relative to staples peers limits meaningful share price outperformance from current levels.”

Colgate-Palmolive scores a Hold consensus rating based on 6 Holds, 3 Buys, and 2 Sells. The average analyst price target of $85.64 implies upside potential of about 9.8% to current levels. Shares have gained 5.7% over the past year.

Related News:
Church & Dwight’s 4Q Profit Tops Analysts’ Estimates; Street Sees 14% Upside
Roper Technologies Dips 7% On 1Q Profit Outlook Miss
FB Financial Ramps Up Dividend By 22%

AstraZeneca will start to supply the European Union with an additional 9 million doses of its vaccine after Europe approved its use to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

This marks another approval for AstraZeneca’s (AZN) vaccine after getting the regulatory nod from the UK. The European Medicines Agency (EMA) granted a so-called conditional marketing authorisation (CMA) based on positive opinion on data from a rolling review of the primary analysis of the Phase 3 study led by the University of Oxford.

Following the review, the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommends two doses of AstraZeneca’s COVID-19 vaccine, to be deployed at a four- to 12-week interval in individuals aged 18 years and older. The dosing regimen demonstrated to be safe and effective in preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose, the CHMP concluded.

“AstraZeneca will deliver 9 million additional doses in the first quarter (40 million in total) compared to last week’s offer & will start deliveries one week earlier than scheduled,” European Commission president Ursula Von der Leyen wrote in a Twitter post on Jan. 31. “The company will also expand its manufacturing capacity in Europe.”  

AstraZeneca is also conducting a large trial in the US and globally. As a result, Oxford University and AstraZeneca expect to enroll up to 60,000 participants globally. AstraZeneca is scheduled to supply up to three billion doses of the vaccine in 2021 globally, pending regulatory approvals. 

“Today’s approval underscores the value of AstraZeneca’s COVID-19 vaccine, which is not only effective and well tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations,” said AstraZeneca CEO Pascal Soriot.

AZN shares have declined 6.3% over the past five days and are up 4.3% over the past year. (See AstraZeneca stock analysis on TipRanks). That’s with a Strong Buy consensus rating backed by 6 Buy ratings versus only 1 Hold rating.

What’s more, the average analyst price target stands at $67.50, which puts the upside potential at a promising 33% in the coming 12 months.

Following the vaccine’s UK approval, AlphaValue analyst Amandeep Goyal upgraded the stock to Buy from Sell as he argues that "sentiment around Astra's share price should improve finally."

Goyal also raised AZN’s premium on peer-based multiples to 40% from 35% to account for prospective incremental cash flows from the Alexion takeover.

Meanwhile, AZN gets a 2 out of 10 on TipRanks' Smart Score system , which implies that the stock is likely to underperform market expectations.

Related News:
Microsoft’s Cloud Services Fuel 2Q Sales Beat; Shares Rise
Starbucks’ Profit Outlook Disappoints; Shares Fall
Texas Instruments’ 4Q Sales Top Estimates; Street Says Hold

Church & Dwight reported better-than-expected 4Q results. Despite the upbeat performance, shares closed 2.9% lower on Friday.

Church & Dwight’s (CHD) 4Q adjusted earnings of $0.53 per share beat Street estimates by a penny and came in ahead of the company’s guidance range of $0.50-$052 per share. However, the bottom-line result declined 3.6% year-over-year, reflecting higher marketing expenses.

Meanwhile, revenue increased 13.2% to $1.3 billion year-over-year and topped analysts’ expectations of $1.26 billion. The consumer product manufacturer reported organic revenue growth of 10.8% primarily driven by a 10.3% increase in volume and a positive product and price mix of 0.5%. (See Church & Dwight stock analysis on TipRanks)

Additionally, Church & Dwight announced a 5.2% increase in its quarterly dividend to $0.2525 per share from $0.24, reflecting an annualized dividend yield of 1.2%.

Management expects 2021 to be another solid year for the company. Church & Dwight forecasts 2021 adjusted EPS in the range of $3-$3.06, reflecting year-on-year growth of 6%-8%. Sales are projected to increase 4.5% on a reported basis and by 3% organically.

Following the earnings release, Oppenheimer analyst Rupesh Parikh assigned a Buy rating and price target of $100 (18.4% upside potential) on the stock. In a note to investors, Parikh wrote, “We look favorably on the company's product portfolio, track record of innovation, competitive position, historical success in adjusting to changing retail environments, management team, and consistent record of execution. We believe CHD management can continue to deliver high-single-digit EPS growth in a likely more volatile backdrop going forward.”

Overall, the Street has a cautiously optimistic outlook, with a Moderate Buy consensus rating based on 3 Buys and 4 Holds. The average analyst price target of $96.17 implies upside potential of about 13.9% to current levels. Shares have gained 16% in the past year.

Related News:
Chevron’s 4Q Sales Miss Analysts’ Estimates; Shares Drop 4%
Honeywell’s 4Q Profit Tops Estimates
Mondelez’s 4Q Profit Beats Analysts’ Estimates; Street Is Bullish